Aseptically withdrawing a plurality of fluid samples from a container is important in many industries such as in the pharmaceutical industry, food industry, breweries or biotech applications. Such industries use large tanks or containers preparing and treating liquids as well as dissolving and mixing components therein. These liquids may include aqueous pharmaceutical formulations or nutritional products such as beer or dairy products.
There is a need to sample such liquids throughout the manufacturing process to ensure quality control and process monitoring. This includes chemical, biological and/or physical analysis as well as screening for process intermediates for monitoring the progression of chemical reactions.
Typically, such containers comprise at least one opening into which a suitable valve, port or related mechanism can be fitted. The processing of the fluid, such as the production of pharmaceuticals, is then typically conducted under closed conditions. Microbiological or biochemical reactions such as fermentations require an aseptically isolated space within a bioreactor from which samples have to be withdrawn and analysed for monitoring status and progress of reactions.
An aseptic and reproducible sampling of a plurality of samples from such containers remains a technical challenge. Commonly known devices use fittings welded to the container with one or more valves attached to the fitting. One or more liquid samples may be withdrawn through flexible tubes and attached sampling bags, bottles or any receptacle. Liquid remaining in the valve may be transferred to subsequent samples or may give rise to bacterial contamination. In addition, several known sampling systems require the piercing of a septum with a hypodermic needle with the associated disadvantages, which include introducing a foreign item or particles from the membrane into the process.
WO 2007/143426 A2 relates to a sampling device with a sanitary fitting having a first port, and a rotatable sample coupling with two or more second ports. Rotating the sample coupling causes the first port to sequentially align with each of the second ports, thus allowing fluid access through the aligned first and second ports.
U.S. Pat. No. 5,823,222 A discloses a sampling system comprising a nipple with a coupling means, the nipple providing a fluid channel. The coupling means seals the nipple while a stopping means engages the coupling means to permit flow of the fluid. The fluid flows through the coupling means into a sterile sample container. The nipple and the coupling means are subsequently disengaged and the flow is terminated by the stopping means. In a final step, the coupling means is cleaned prior to further sampling.
EP 1548420 B1 relates to a fluid sampling device with a port insert having several channels receiving elongated members for selectively opening and closing the channels by linear displacement. The elongated members carry a cap at their distal ends for preventing undesired pulling out of the members from the channels.
US 2008/022785 A1 discloses a fluid sampling device with a first member having a plurality of channels, and a second member having a through passage, wherein the first member and said second member are rotatable with respect to each other such that each of the channels of the first member can be sequentially aligned with the passage of the second member.
The above described prior art valves or fittings typically have a complicated design which presents important drawbacks and technical challenges as well as adding to the overall cost of production and operation. In addition, there is a risk of cross-contamination between different samples or old sample residues being carried over into later samples using the prior art systems.
In one aspect, the disclosed embodiments are directed to providing an improved sampling device for withdrawing a plurality of fluid samples from a container.
In another aspect, the disclosed embodiments are directed to providing a cost-efficient and simple design of a sampling device, thus facilitating the manufacturing and operation of said device.
In another aspect, the disclosed embodiments are directed to providing a sampling device design that minimises the risk of cross-contamination between fluid samples.
In another aspect, the disclosed embodiments are directed to providing a sampling device resulting in improved work safety and decreased risk of maloperation for operating staff.
In yet another aspect, the disclosed embodiments are directed to design an easily disposable sampling device.
In another aspect, the disclosed embodiments are directed to design a flexible sampling system allowing for the sampling of a variable amount of samples from a fluid container.